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OncoMatch/Clinical Trials/NCT06015503

A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

Is NCT06015503 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PLB1004 for non-small-cell lung cancer.

Phase 2RecruitingAvistone Biotechnology Co., Ltd.NCT06015503Data as of May 2026

Treatment: PLB1004It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR ex20ins mutation

Participants with EGFR ex20ins mutation.

Disease stage

Required: Stage IIIB, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines

Must have received: platinum-based chemotherapy — advanced disease

platinum containing ... systemic therapy

Must have received: immunotherapy — advanced disease

immunotherapy containing systemic therapy

Cannot have received: monoclonal antibody targeting EGFR

Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks

Cannot have received: monoclonal antibody targeting HER2

Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks

Cannot have received: monoclonal antibody targeting VEGFR

Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks

Cannot have received: cytotoxic chemotherapy

Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days

Cannot have received: anticancer herbal medicine

Any anticancer herbal medicine within 7 days

Cannot have received: anti-EGFR TKI

Exception: for the EGFR ex20ins mutation

Any anti-EGFR TKI for the EGFR ex20ins mutation

Cannot have received: third-generation anti-EGFR TKI

Exception: during the treatment having achieved a best overall response of the partial response or complete response

Any third-generation anti-EGFR TKI during the treatment having achieved a best overall response of the partial response or complete response

Lab requirements

Blood counts

Participants must have specific organ and bone marrow function.

Kidney function

Participants must have specific organ and bone marrow function.

Liver function

Participants must have specific organ and bone marrow function.

Participants must have specific organ and bone marrow function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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